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FDA Drug Application 010187 by NOVARTIS

Application Number010187
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/5/1955N16556000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 5/10/2007
AP012/5/1955N24070000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089090.pdf 11/20/2009
AP02/21/1975SCS       
AP09/9/1975SCS       
AP09/9/1975SCS       
AP09/9/1975SCS       
AP010/12/1979SCS       
AP09/9/1975SCS       
AP02/15/1980SCF       
AP03/6/1980SCF       
AP02/18/1981SLR       
AP010/10/1985SCS       
AP03/13/1985SCS       
AP01/21/1986SLR       
AP012/8/1987SCS       
AP07/9/1997SLR       
AP03/9/1990SCM       
AP03/7/1994SCS       
AP07/9/1997SLR       
AP05/31/1994SCS       
AP08/19/1994SCM       
AP06/1/1995SCS       
AP07/9/1997SLR       
AP012/15/1995SLR       
AP07/9/1997SLR       
AP02/20/1998SLR       
AP04/24/1998SCS       
AP08/12/1998SCS       
AP09/17/1998SCM       
AP011/24/1998SCM       
AP04/13/1999SCP       
AP01/11/2000SCM       
AP05/21/2004SLR8679057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf 5/27/2004
AP05/21/2004SLR8680058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf 5/27/2004
AP08/15/2001SCS       
AP01/11/2002SLR3218060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10187s60ltr.pdf 1/11/2002
AP05/29/2002SCM       
AP06/12/2002SCS       
AP08/8/2006SLR14648066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf 8/9/2006
AP08/8/2006SLR14679066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf 8/11/2006
AP08/8/2006SLR14680067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf 8/11/2006
AP08/8/2006SLR14649067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf 8/9/2006
AP04/25/2007SLR16354069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf 5/1/2007
AP04/25/2007SLR16396069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010187s069,018029s040,021284s011ltr.pdf 5/1/2007
AP011/15/2010SLR26974072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.pdf 11/17/2010
AP011/15/2010SLR26982072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010187s072,018029s042,021284s017ltr.pdf 11/18/2010
AP012/9/2010SLR27271073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s073lbl.pdf 12/10/2010
AP012/9/2010SLR27288073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf 12/15/2010
AP06/7/2013SLR36253074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s074,018029Orig1s044,021284Orig1s019ltr.pdf 6/11/2013
AP06/7/2013SLR36259074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.pdf 6/11/2013
AP010/25/2013SCM       
AP02/7/2014SCM       
AP012/13/2013SLR38048077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s077,018029Orig1s047,021284Orig1s023ltr.pdf 12/16/2013
AP012/13/2013SLR38058077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf 12/17/2013
AP07/14/2014SCM       
AP04/17/2015SLR42588080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010187Orig1s080,018029Orig1s049,021284Orig1s027ltr.pdf 4/21/2015
AP04/17/2015SLR42605080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf 4/21/2015
AP010/2/2015SCM       
AP05/27/2016SCM       




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